PAF v AbbVie excessive pricing case the Netherlands

On 14 May 2024, the Pharmaceutical Accountability Foundation (PAF) had their first hearing in their case against Abbvie at the Amsterdam District Court. The case concerns Abbvie’s pricing practices for its blockbuster drug Humira (adalimumab), one of the world’s best-selling pharmaceutical products. PAF’s legal action is being brought under the Dutch Collective Settlement of Mass Damage Act (WAMCA), a recent legislative amendment that allows for collective redress in cases of mass damage.


Humira (adalimumab) is a biological medication developed by AbbVie (formerly part of Abbott Laboratories) for the treatment of autoimmune diseases. It belongs to a class of medicines known as tumor necrosis factor (TNF) inhibitors, which work by suppressing the immune system response that causes inflammation. Humira was first launched in 2003 for the treatment of rheumatoid arthritis.

Over time, Humira’s efficacy in treating a variety of autoimmune diseases was demonstrated, leading to its approval for additional indications, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and others. Its versatility across multiple autoimmune diseases has led to its tremendous commercial success. Between 2012 and 2020, Humira was the world’s best-selling pharmaceutical product. The drug has generated more than $228 billion in sales through the end of 2023./1/

Legal Action

PAF began its action towards Abbvie in 2021 by sending a letter to AbbVie, calling upon AbbVie to account for the excessive price it charged for Humira between 2004 and 2018 in the Netherlands. The letter requested a meeting with Abbvie to try to resolve the matter out of court. After Abbvie failed to provide a substantive response to PAF’s letter by the specified date, PAF launched a case in February 2023 against AbbVie for unfair, excessive pricing practices on its blockbuster drug Humira. PAF is asking the court to declare that AbbVie acted unlawfully for the excessive pricing it charged for Humira between 2004-2018, based on internationally recognized human rights principles and AbbVie’s unwritten duty of care enshrined in Dutch tort law. The Foundation is also of the view that Abbvie breached both EU and domestic competition rules by abusing its dominant market position for Humira. AbbVie responded to the subpoena, claiming that PAF’s case should be deemed inadmissible for various procedural reasons, including the contention that PAF was not directly harmed by AbbVie’s pricing practices.

Legal Precedent and Collective Actions

PAF’s class action is based on Article 3:305a of the Dutch Civil Code (DCC). In 2020, the Collective Settlement of Mass Damage Act (WAMCA), came into force in the Netherlands. This legislation amended the pre-existing collective action mechanism in the Netherlands to allow for monetary damages as a form of collective redress and introduced a more streamlined litigation procedure. Prior to the WAMCA, there was no specific mechanism to deal with parallel collective actions and to prevent the filing of several or parallel collective actions. Under the new regime, any judgment will be binding on a group of affected persons (as defined by the court), allowing the courts to consolidate all collective actions relating to the same event./2/

Some fear that WAMCA could lead to an increase in American-style mass claim culture, spurred on by litigation funders and the prospect of large pecuniary payouts./3/ However, a 2024 study found that collective compensation claims remain low./4/ Indeed, the majority of claims brought through WAMCA concern non-compensatory actions.

WAMCA also established admissibility criteria for collective actions, seeking to balance access to collective relief with admissibility safeguards. As a result, the WAMCA process is largely bifurcated into two stages: the preliminary admissibility phase and then the substantive phase and assessment of the claim. The first hearing between PAF and AbbVie on May 14th concerned this initial admissibility stage.

14 May 2024 Court Hearing

On 14 May 2024, PAF had its first hearing against Abbvie at the Amsterdam District Court. During this phase of the proceedings and in this hearing, the court examined whether PAF can indeed bring a collective action using the WAMCA legislation by assessing whether PAF meets the admissibility and qualification requirements under the WAMCA. To be admissible, PAF had to demonstrate that a collective action is more efficient and effective than individual actions and that PAF is not without merit at the time that the proceedings are initiated.

The proceedings were held in Dutch. The following summary is based on an unofficial translation of the pleading notes from PAF and AbbVie.

Pharmaceutical Accountability Foundation’s Pleadings

PAF’s lawyer, Rogier Meijer, began his opening statement by highlighting the former Dutch Health Minister Bruins’ acknowledgement of the scarcity of health care budgets, underscoring the challenge of making decisions with finite resources, where every euro spent necessarily displaces care elsewhere. PAF accused AbbVie of perpetuating such displacement by charging excessively high prices for its drug Humira over an extended period of time. PAF claims that this unnecessary displacement of care cost the Dutch health care system EUR 1.2 billion. This displacement is quantified not only in financial terms, but also in the loss of as many as 16,300 quality adjusted life years (QALYs)./5/

PAF’s economist estimate of the impact of excessive prices on the loss of quality adjusted lives in the Netherlands seems to assume that the national health care outlays are fixed, and that excessive payments to AbbVie for Humira came at the cost of other outlays that would, on the margin, save one quality adjusted life year in the Netherlands for EUR 73,000. PAF’s economist also estimated that the excess profits made by AbbVie were not reinvested in the healthcare system, and that a minimum of 7,200 and up to 16,300 healthy life years could have been gained in the period when Humira enjoyed patent protection in the Netherlands.

PAF clarified that its legal action isn’t aimed at discrediting AbbVie’s contributions to healthcare. Rather, its fundamental interest is to prevent the healthcare system from being burdened with excessive drug prices that impede access to necessary care. While PAF acknowledged the need for a reasonable return on investment in pharmaceutical research and development, it contends that AbbVie’s pricing of Humira far exceeded what was proportionate, leading to unlawful conduct.

PAF disputed the notion that seeking a declaratory judgment from the court would set a precedent for future litigation. Instead, PAF contended that the interest is in establishing a legal relationship with AbbVie and the group of affected persons that represents the broader societal interest in accessible healthcare. Moreover, PAF argued that the pursuit of a declaratory judgment under civil law serves a broader purpose beyond financial interests. By seeking legal clarity on whether AbbVie acted unlawfully, PAF aims to assert and delineate the boundaries of AbbVie’s pricing behavior. As such, PAF is not seeking damages, but rather a declaratory judgment that holds AbbVie accountable for its pricing practices.

Regarding admissibility, PAF claimed that it is admissible under the old legal framework for collective actions and also under the recently introduced WAMCA. Under the WAMCA, PAF argued that its action falls within the scope of the legislation because AbbVie’s allegedly unlawful conduct continued beyond November 2016.

To summarize, PAF tried to characterize its collective action in this case as a public interest endeavor aimed at securing access to care for all members of society, rather than the pursuit of individual damages. Rather than seeking monetary compensation for specific damages suffered, PAF’s overarching goal is to advance the broader societal interest in affordable and accessible health care.

In its closing statement, PAF reiterated their commitment to pursuing justice and accountability in the case against AbbVie for excessive pricing of Humira and emphasized the importance of ensuring fair access to healthcare for all.

AbbVie’s Pleadings

In response to PAF’s opening statement, AbbVie argued that PAF’s collective action should be ruled inadmissible. It did so based on arguments that highlighted the supposed lack of sufficient interest, jurisdictional issues and the inadequacy of the evidence provided. AbbVie argued that the focus of the legal debate in this phase should be admissibility and jurisdiction, rather than on substantive issues surrounding Humira.

AbbVie first argued that PAF’s pursuit of a precedent lacked sufficient legal weight, as Dutch law requires more than mere precedent-seeking for a collective action to proceed. AbbVie also argued that PAF’s objectives, asking the court to set concrete standards for drug prices, were beyond the court’s jurisdiction. They criticized PAF for failing to adequately demonstrate how the requested declaratory judgments would benefit the represented group of affected persons, attempting to cast doubt on the interests served by PAF’s legal action.

Regarding jurisdictional issues and the legal basis of PAF’s action within the Dutch legal system, AbbVie argued that PAF’s action does not meet the specific requirements set out in WAMCA. They further emphasized that the action does not solely serve general interest but rather target a specific group of identifiable individuals. AbbVie further questions the level of support of PAF’s action, highlighting the relatively small number of signatories on PAF’s website compared to the total number of potentially affected individuals. They further contend that this legal case may be a stepping stone for insurers to initiate action for damage against AbbVie.

In addressing evidence, AbbVie contends that there is inadequate evidence provided and PAF failed to meet the required standard of proof, particularly regarding the alleged violation of competition law. AbbVie claims that PAF’s claim lacks substantive evidence and lacks understanding of market dynamics in the pharmaceutical industry.

In conclusion, AbbVie requested the court to make decisions affecting the substance of the case provisionally or to limit them to the admissibility phase of the procedure. Overall, AbbVie’s arguments attempt to undermine the credibility of PAF and weaken the legal basis of their claims.

Adjourning of the hearing and next steps

The court posed questions to both parties. On June 26th the court will rule on procedural grounds on whether or not PAF’s case can proceed to its merits. In its admissibility judgment, the court can determine the contents of the claim and the narrowly defined group.

Since the members of the narrowly defined group in the suit are bound to the outcome of the collection, there are opt out proceedings upon which persons domiciled or resident or the Netherlands can opt out. Additionally, this period allows for opt-in actions for persons not domiciled or residing in the Netherlands (1018f(5) DCCP).


If PAF’s case proceeds, it could serve as a precedent to address excessive pharmaceutical pricing. The core of PAF’s case touches upon a balance between innovation and access in healthcare. Whereby governments offer a number of direct and indirect subsidies and incentives for drug development, including exclusive rights to market, manufacture and sell a particular product. These incentives are not limited to monopolies conferred by patents, but also regulatory barriers to entry by generic or biosimilar products.

/1/ Revenues, Drug Database.; see also Pharmaceutical Accountability Foundation, Humira (adalimumab).

/2/ Horeman, D., & de Monchy, M. (2022). Unlocking the Wamca: A practical guide to the new collective actions regimes in the Netherlands. De Brauw Blackstone Westbroek.

/3/ Tillema, I. (2022). Dutch collective actions and the rise of entrepreneurial actors: Navigating between access to justice and a claim culture. In Frontiers in Civil Justice (pp. 238-258). Edward Elgar Publishing.

/4/ van Doorn, K., 2024. Drie-en-een-half jaar collectieve (schadevergoedings) acties.: Een inhoudelijke analyse van het centraal register voor collectieve vorderingen. Nederlands Juristenblad, 2024(2), pp.84-95.

/5/ E. Adang et al, Verdringingseffecten binnen het Nederlandse zorgstelsel, Nijmegen 2018, p. 11 and 40.